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Coppertone sunscreen spf 60 - Medication Information

Product NDC Code 66800-8007
Drug Name

Coppertone sunscreen spf 60

Type Brand
Active Ingredients
Avobenzone 3 g/100g
Homosalate 15 g/100g
Octisalate 5 g/100g
Octocrylene 10 g/100g
Route TOPICAL
Dosage Form AEROSOL, SPRAY
Application Number M020
Labeler Name Beiersdorf Inc
Packages
Package NDC Code Description
66800-8007-1 142 g in 1 can (66800-8007-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions ■ shake well before each use ■ spray liberally and spread evenly by hand 15 minutes before sun exposure ■ hold container 4 to 6 inches from the skin to apply ■ do not spray directly into face. Spray on hands then apply to face. ■ do not apply in windy conditions ■ use in a well-ventilated area ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m. – 2 p.m. ■ wear long-sleeve shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients SD alcohol 40-B (46.2% v/v), isobutane, butyloctyl salicylate, acrylates/octylacrylamide copolymer, polyester-8, ethylhexyl methoxycrylene, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, diethylhexyl syringylidenemalonate, fragrance

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Coppertone Sunscreen SPF 60 Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10% ISOBUTANE BUTYLOCTYL SALICYLATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE DIETHYLHEXYL SYRINGYLIDENEMALONATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) FRAGRANCE CLEAN ORC0600327 ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) ALCOHOL BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE ETHYLHEXYL METHOXYCRYLENE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Coppertone Sunscreen Spray Sport 60+ 4-in-1 Performance Stops up to 98% UV Rays Resists Sweat + Heat + Water Free of Oxybenzone, Octinoxate, PABA, Phthalates & Dyes Water Resistant (80 Minutes) Broad Spectrum SPF 60+ Sport

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information ■ protect this product from excessive heat and direct sun ■ store between 20° to 25°C (68° to 77°F) ■ may stain or damage some fabrics or surfaces

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-866-288-3330

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product ■ keep away from face to avoid breathing it ■ keep out of eyes. Rinse with water to remove. ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Flammable: Do not use near heat, flame, or while smoking

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API